An observational study in Unresectable Triple-negative Breast Cancer and Metastatic Triple-negative Breast Cancer, sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-09.
Sponsored by Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company (part of Daiichi Sankyo) · Observational
There are no real-world data available on the effectiveness and safety of Dato-DXd in adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. This NIS will investigate the effectiveness of Dato-DXd, the demographic and clinical characteristics of the patients, and treatment patterns.
This is a multi-center, multi-country, prospective, NIS that will collect real-world clinical data on effectiveness, safety and patient reported tolerability data on oral mucositis/stomatitis and ocular surface events by using linguistically validated diaries from adult patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy. In addition, data on quality of life will be collected using validated patient reported outcomes (EQ5D-5L, EQ-VAS).
1,163 studies on the registry are indexed under Triple Negative Breast Neoplasms; 447 are open to participants now.
This study's planned enrollment of 400 is above the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.
Browse Triple Negative Breast Neoplasms studies →Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy.
Key Inclusion Criteria:
Histologically or cytologically documented locally recurrent inoperable or metastatic TNBC defined as:
Key Exclusion Criteria:
Patients with unresectable or metastatic triple-negative breast cancer who are not candidates for PD-1/PD-L1 inhibitor therapy who will be treated with Dato-DXd based on clinical routine care according to the proposed indication statement in the Summary of Product Characteristics (SmPC).
Drug: Dato-DXd
This is a non-interventional study and no drug was administered.
Real-world Time to Next Treatment (rwTTNT1)
rwTTNT1 is defined as the length of time from index date to the date the patient received an administration of their next systemic treatment regimen or to their date of death if the patient died before initiation of next systemic treatment.
Time frame: From index date to time up to approximately 50 months
Treatment Patterns of Neoadjuvant and Adjuvant Therapies
Time frame: From index date up to approximately 50 months
Real-world Time to Next Treatment 2 (rwTTNT2)
rwTTNT2 is defined as the time from the start of Dato-DXd administration (1L) to the start of the second subsequent therapy (3L) or death.
Time frame: From index date up to approximately 50 months
Real-world Time to Permanent Treatment Discontinuation of the Index Treatment (rwTTD1)
rwTTD1 is defined as the time between start of Dato-DXd administration and last administration or death.
Time frame: From index date up to approximately 50 months
Reasons for rwTTNT1 and rwTNT2 Event
rwTTNT1 and rwTNT2 are defined as the number of participants categorized according to the reason for rwTTNT1 or rwTTNT2 event. Reasons may include disease progression, adverse events, death, or others.
Time frame: From index date up to approximately 50 months
Real-world Overall Survival (rwOS)
rwOS is defined as time from index date to date of death from any cause.
Time frame: From index date up to approximately 50 months
Number of Participants Reporting Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Drug Reactions (ADRs), Serious Adverse Drug Reactions (SADRs), and Adverse Events of Special Interest (AESIs)
Time frame: From index date up to approximately 50 months
Prophylactic and Reactive Treatments Used for AESI Management
AESI management is defined as the clinical management of physician-reported adverse events of special interest (AESIs), including prophylactic and reactive interventions. Data collected may include treatment name, dose, frequency, and duration of use.
Time frame: From index date up to approximately 50 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Triple Negative Breast Neoplasms →
Daiichi Sankyo Europe, GmbH, a Daiichi Sankyo Company →